Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-05 @ 2:31 PM
Study NCT ID:
NCT02287402
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2014-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postmarketing Clinical Study on AO-128
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C054577', 'term': 'AO 128'}, {'id': 'C102817', 'term': 'voglibose'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hitoshi.onouchi@takeda.com', 'phone': '+81-6-6204-5116', 'title': 'Hitoshi Onouchi', 'organization': 'Japan Development Center, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited'}, 'certainAgreement': {'otherDetails': 'The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of open-label study drug until the day of the last dose of open-label study drug.', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.', 'otherNumAtRisk': 197, 'otherNumAffected': 165, 'seriousNumAtRisk': 197, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 7}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Herpes zoster oticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Laryngeal cancer stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Type 2 Diabetes mellitus', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Normoglycemia', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'IGT', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.', 'description': 'Frequency tabulations of the "assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in the "Full Analysis Set".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All participants who received at least 1 dose of open-label study drug.'}, {'type': 'PRIMARY', 'title': 'Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Type 2 Diabetes mellitus', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Normoglycemia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'IGT', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up at Week 12, 24, 36, and 48', 'description': 'Frequency tabulations of the "assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in patients who proceeded to the follow-up in the "Full Analysis Set".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.'}, {'type': 'SECONDARY', 'title': 'Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Day 168', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 336', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 504', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 672', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 168, 336, 504, and 672', 'description': 'The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the "time to progression to Type 2 Diabetes mellitus in the treatment period" in the "Full Analysis Set".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All participants who received at least 1 dose of open-label study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Day 168', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 336', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 504', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 672', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 168, 336, 504, and 672', 'description': 'The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the "time to progression to type 2 diabetes mellitus in the treatment period" in the "Full Analysis Set".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All participants who received at least 1 dose of open-label study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Day 168', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 336', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 504', 'categories': [{'measurements': [{'value': '50.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 672', 'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 168, 336, 504, and 672', 'description': 'The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the "time to improvement to normoglycemia in the treatment period" in the "Full Analysis Set".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All participants who received at least 1 dose of open-label study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Day 168', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 336', 'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 504', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 672', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 168, 336, 504, and 672', 'description': 'The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the "time to improvement to normoglycemia in the treatment period" in the "Full Analysis Set".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All participants who received at least 1 dose of open-label study drug.'}, {'type': 'SECONDARY', 'title': '2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '166.7', 'spread': '17.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '148.0', 'spread': '34.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '153.2', 'spread': '36.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '155.6', 'spread': '36.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '155.6', 'spread': '33.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '163.2', 'spread': '31.89', 'groupId': 'OG000'}]}]}, {'title': 'The end of the treatment period', 'categories': [{'measurements': [{'value': '142.8', 'spread': '37.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 24, 48, 72, 96, 120, and the end of the treatment period', 'description': 'Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the "Full Analysis Set."', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All participants who received at least 1 dose of open-label study drug.'}, {'type': 'SECONDARY', 'title': '2-Hour Plasma Glucose During 75 g OGTT at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Follow-up at Week 0', 'categories': [{'measurements': [{'value': '119.4', 'spread': '15.82', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 12', 'categories': [{'measurements': [{'value': '148.3', 'spread': '35.26', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 24', 'categories': [{'measurements': [{'value': '147.9', 'spread': '29.69', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 36', 'categories': [{'measurements': [{'value': '145.9', 'spread': '18.94', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 48', 'categories': [{'measurements': [{'value': '138.3', 'spread': '20.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up at week 0, 12, 24, 36, and 48', 'description': 'Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the "Full Analysis Set."', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.'}, {'type': 'SECONDARY', 'title': 'Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '5.45', 'spread': '0.331', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.35', 'spread': '0.305', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '5.30', 'spread': '0.302', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '5.37', 'spread': '0.317', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '5.34', 'spread': '0.285', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '5.41', 'spread': '0.269', 'groupId': 'OG000'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '5.45', 'spread': '0.256', 'groupId': 'OG000'}]}]}, {'title': 'The end of the treatment period', 'categories': [{'measurements': [{'value': '5.35', 'spread': '0.323', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.', 'description': 'Summary statistics were calculated at each assessment time point for the HbA1c in the "Full Analysis Set."', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All participants who received at least 1 dose of open-label study drug.'}, {'type': 'SECONDARY', 'title': 'HbA1c at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Follow-up at Week 0', 'categories': [{'measurements': [{'value': '5.23', 'spread': '0.292', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 12', 'categories': [{'measurements': [{'value': '5.27', 'spread': '0.330', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 24', 'categories': [{'measurements': [{'value': '5.26', 'spread': '0.326', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 36', 'categories': [{'measurements': [{'value': '5.20', 'spread': '0.301', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 48', 'categories': [{'measurements': [{'value': '5.28', 'spread': '0.260', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up at Week 0, 12, 24, 36, and 48', 'description': 'Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '70.74', 'spread': '13.708', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '69.74', 'spread': '13.659', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '69.91', 'spread': '13.658', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '69.25', 'spread': '13.632', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '70.03', 'spread': '13.955', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '69.25', 'spread': '14.484', 'groupId': 'OG000'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '68.82', 'spread': '14.835', 'groupId': 'OG000'}]}]}, {'title': 'The end of the treatment period', 'categories': [{'measurements': [{'value': '68.96', 'spread': '13.892', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period', 'description': 'Summary statistics were calculated at each assessment time point for the body weight in the "Full Analysis Set."', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - All participants who received at least 1 dose of open-label study drug.'}, {'type': 'SECONDARY', 'title': 'Body Weight at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'classes': [{'title': 'Follow-up at Week 0', 'categories': [{'measurements': [{'value': '67.60', 'spread': '13.023', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 12', 'categories': [{'measurements': [{'value': '67.76', 'spread': '13.035', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 24', 'categories': [{'measurements': [{'value': '68.87', 'spread': '11.703', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 36', 'categories': [{'measurements': [{'value': '70.13', 'spread': '11.754', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up at Week 48', 'categories': [{'measurements': [{'value': '68.72', 'spread': '13.844', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up at Week 0, 12, 24, 36, and 48', 'description': 'Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '64 participants who completed the Treatment Period did not continue to Follow-up.', 'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 30 investigative sites in Japan from 9 March 2010 to 15 November 2012.', 'preAssignmentDetails': 'Participants with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy receive one AO-128 0.2 mg tablet orally 3 times a day before meals.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '9.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '197', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2014-10-22', 'resultsFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2014-11-05', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-08', 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)', 'timeFrame': 'Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.', 'description': 'Frequency tabulations of the "assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in the "Full Analysis Set".'}, {'measure': 'Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)', 'timeFrame': 'Follow-up at Week 12, 24, 36, and 48', 'description': 'Frequency tabulations of the "assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in patients who proceeded to the follow-up in the "Full Analysis Set".'}], 'secondaryOutcomes': [{'measure': 'Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method', 'timeFrame': 'Day 168, 336, 504, and 672', 'description': 'The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the "time to progression to Type 2 Diabetes mellitus in the treatment period" in the "Full Analysis Set".'}, {'measure': 'Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function', 'timeFrame': 'Day 168, 336, 504, and 672', 'description': 'The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the "time to progression to type 2 diabetes mellitus in the treatment period" in the "Full Analysis Set".'}, {'measure': 'Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method', 'timeFrame': 'Day 168, 336, 504, and 672', 'description': 'The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the "time to improvement to normoglycemia in the treatment period" in the "Full Analysis Set".'}, {'measure': 'Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function', 'timeFrame': 'Day 168, 336, 504, and 672', 'description': 'The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the "time to improvement to normoglycemia in the treatment period" in the "Full Analysis Set".'}, {'measure': '2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)', 'timeFrame': 'Week 0, 24, 48, 72, 96, 120, and the end of the treatment period', 'description': 'Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the "Full Analysis Set."'}, {'measure': '2-Hour Plasma Glucose During 75 g OGTT at Follow-up', 'timeFrame': 'Follow-up at week 0, 12, 24, 36, and 48', 'description': 'Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the "Full Analysis Set."'}, {'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': 'Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.', 'description': 'Summary statistics were calculated at each assessment time point for the HbA1c in the "Full Analysis Set."'}, {'measure': 'HbA1c at Follow-up', 'timeFrame': 'Follow-up at Week 0, 12, 24, 36, and 48', 'description': 'Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."'}, {'measure': 'Body Weight', 'timeFrame': 'Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period', 'description': 'Summary statistics were calculated at each assessment time point for the body weight in the "Full Analysis Set."'}, {'measure': 'Body Weight at Follow-up', 'timeFrame': 'Follow-up at Week 0, 12, 24, 36, and 48', 'description': 'Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Impaired Glucose Tolerance (IGT)']}, 'descriptionModule': {'briefSummary': 'The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose) 0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy, and follow up the progress after the end of treatment in patients who was assessed as normoglycemic.', 'detailedDescription': 'The α-glucosidase inhibitor voglibose was developed by Takeda Pharmaceutical Co. Ltd and is one of the most commonly used oral antidiabetic agents in Japan. Voglibose is used as first-line treatment for improvement of postprandial hyperglycemia in diabetic patients with inadequate response to diet and exercise therapy and as add-on treatment to other oral antidiabetic drugs and insulin. In 2009, voglibose was approved in Japan for the management of prediabetes (IGT).\n\nThis study was a single-group, multi-center, open-label study. The study period consisted of a screening period of 1 week or less, a treatment period of 96 weeks or more, and a follow-up period of 48 weeks. However, if a patient was assessed as having type 2 diabetes mellitus or normoglycemia, the treatment period was to be ended, and only those assessed as normoglycemic were to proceed to follow-up. Follow-up was also to be terminated if patients were assessed as having IGT or type 2 diabetes mellitus during follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients on diet therapy and exercise therapy for 3 to 6 months prior to the start of screening, with baseline (fasting ) plasma glucose \\< 126 mg/dL and 2-hour plasma glucose of 140 to 199 mg/dL (revised WHO criteria) during a 75 g oral glucose tolerance test (OGTT) in the screening period\n2. Patients meeting any of 1 through 4 below:\n\n * 1\\) Comorbid hypertension or high normal blood pressure\n * 2\\) Comorbid dyslipidemia\n * 3\\) Comorbid obesity\n * 4\\) Patients with up to a second-degree family history of type 2 diabetes mellitus\n3. Patients with HbA1c \\< 6.5% in the screening period\n4. Male or female patients at least 20 years of age at the time informed consent was obtained\n5. Treatment category: Outpatient\n\nExclusion Criteria:\n\n1. Patients previously diagnosed with diabetes mellitus.\n2. Patients with apparent impaired glucose metabolism or with a disease or condition potentially involving impaired glucose metabolism.\n3. Patients with serious hepatic impairment.\n4. Patients with serious renal impairment.\n5. Patients with serious cardiac, cerebrovascular, pancreatic, hematologic, or other disease.\n6. Patients with a history of intestinal obstruction or a history of laparotomy within 6 months (24 weeks) before the start of screening.'}, 'identificationModule': {'nctId': 'NCT02287402', 'briefTitle': 'Postmarketing Clinical Study on AO-128', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Postmarketing Clinical Study on AO-128', 'orgStudyIdInfo': {'id': 'AO-128/OCT-910'}, 'secondaryIdInfos': [{'id': 'JapicCTI-101004', 'type': 'OTHER', 'domain': 'JapicCTI'}, {'id': 'U1111-1163-1618', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AO-128 0.6 mg', 'description': 'One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.', 'interventionNames': ['Drug: AO-128']}], 'interventions': [{'name': 'AO-128', 'type': 'DRUG', 'otherNames': ['Voglibose', 'BASEN'], 'description': 'AO-128 tablet', 'armGroupLabels': ['AO-128 0.6 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}